One-4-ALL Initiative

NCT05454969 | Recruiting

• 1 other identifier: 22-0995
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to improve health outcomes of individuals and populations, enhance the patient experience, reduce the per capita cost of care, and ensure the well-being of our healthcare providers (quadruple aim). These goals are increasingly difficult to achieve, given the challenges of changes to workflow, staffing shortages, and increased costs brought on by the COVID-19 pandemic. Further, the pandemic brought to light the critical need to transform healthcare access for our racially and culturally minoritized and low-income families that have long been victims of health disparities, specifically with poorer health outcomes.

Conditions

Literacy; Burden, Caregiver; Health Care Utilization

Outcome Measures

Primary Outcomes (4)

• Health care quality

  Health care quality will be assessed using six domains; safety, effective, patient-centered, timely, efficient, and equitable. Likert scale 1-5, higher score is best.

  post-intervention (12 weeks)

• Provider satisfaction

  Provider job satisfaction including level of burden and overall job satisfaction. Likert scale 1-5, higher score is best. physical and mental health

  post-intervention (12 weeks)

• Patient satisfaction

  Patient's satisfaction of the program tool. Likert scale 1-5, higher score is best. literacy of the patient \& their family, patient \& family anxiety pre-surgery.

  post-intervention (12 weeks)

• Acceptability of program tool

  Patient's ability to engage and understand the program tool. Likert scale 1-5, higher score is better.

  post-intervention (12 weeks)

Study Arms (2)

One-4-ALL Initiative

ACTIVE COMPARATOR

The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.

Behavioral: One-4-ALL Initiative

Control

PLACEBO COMPARATOR

Will receive standard care.

Behavioral: Control

Interventions

One-4-ALL Initiative BEHAVIORAL

We can successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.

One-4-ALL Initiative

Control BEHAVIORAL

Patients will receive standard of care.

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.

You may not qualify if:

• None.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Literacy; Caregiver Burden; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Communication; Behavior; Stress, Psychological; Behavioral Symptoms; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Jill Landsbaugh Kaar, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Landsbaugh Kaar, PhD

CONTACT

17207773571; jill.kaar@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial to examine pre-post differences between individuals that use the app versus the standard of care.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 12, 2022
• Study Start: September 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)